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Post by Deleted on May 11, 2017 7:39:42 GMT -5
peppy Typo: RAA = rapid-acting analog
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Post by peppy on May 11, 2017 7:49:02 GMT -5
peppy Typo: RAA = rapid-acting analog heh, thank you. Kastanes, my take on Fiasp. Nicotine was added and a different protein, it is still a subq analog with the numbers tweaked in comparison studies. The number tweaks can be seen in the grafts. There is no faster acting, ultra whatever name that is put on this stuff, than afrezza. Afrezza, the lungs, the alveoli, the capillary system running underneath that does the O2 CO2 exchange, their is no faster way into the blood steam to the liver. www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004046/WC500220940.pdf
Laura K regarding Afrezza: "The stuff is magic." "If you have a forward thinking endo"
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Post by mnholdem on May 11, 2017 8:04:18 GMT -5
peppy Typo: RAA = rapid-acting analog @kastanes , another error you made is saying that rapid-acting analogs are not insulin. They are classified as insulin analogs rather than the unaltered "insulin human" used in Afrezza.
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Post by Deleted on May 11, 2017 8:19:07 GMT -5
mnholdem when is an insulin analog no longer an analog of insulin?
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Post by liane on May 11, 2017 8:30:07 GMT -5
mnholdem when is an insulin analog no longer an analog of insulin? I'll take a stab - insulin analogs are engineered and are structurally different from native insulin, often varying by single amino acid. The analog can still bind to insulin receptors in the body, but the structural change can impart different kinetics.
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Post by Deleted on May 11, 2017 8:40:49 GMT -5
So as long as the analog binds to the insulin receptor it is classified as an insulin analog. Do any analogs not bind to the insulin receptor?
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Post by agedhippie on May 11, 2017 8:44:45 GMT -5
The reason afrezza was not given the ultra label is the 171 and 175 studies had nothing to do with speed of action. They were about A1c which is like comparing "miles per gallon" to how fast a car can go. They are very much different. If afrezza gets ultra first - Fiasp will have to show non-inferiority. I suspect BP's plan was by now MNKD would be bankrupt. The problem is that the inferiority measure is against HbA1c and Fiasp has trial data supporting superiority over analogs whereas Afrezza doesn't. Shifting to time in range helps but that requires educating the market which takes time. A better and quicker line is probably quality of life since that is an understood metric. I can see the argument that gets used already and it will be that Afrezza requires follow up doses to be effective whereas Fiasp doesn't which will give better long term results. The trouble is that their characteristics make each good at particular roles; Fiasp for meal time, Afrezza for corrections.
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Post by agedhippie on May 11, 2017 8:49:32 GMT -5
So as long as the analog binds to the insulin receptor it is classified as an insulin analog. Do any analogs not bind to the insulin receptor? No.
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Post by liane on May 11, 2017 8:57:10 GMT -5
So as long as the analog binds to the insulin receptor it is classified as an insulin analog. Do any analogs not bind to the insulin receptor? Here's a little nighttime reading on insulin/analogs: insulin.pdf (302.76 KB)
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Post by Deleted on May 11, 2017 9:21:02 GMT -5
The call wasn't inherently bad, and the call wasn't inherently good. There was nothing of note yesterday other than they are on file with a country in the Middle East. No significant updates on label, Epi, Juvenile approval, or sales trajectory was mentioned yesterday. In sum, the street has no reason to believe anything of note will be happening to MNKD in the next quarter, aside from a potential international approval. Sales are flat and Mike gave no reason, that I heard, to believe we'll see significant increases any time soon. Perhaps we will, but I'm skeptical based on what we've seen thus far and a considerable amount of inaccurate guidance that we've heard from the company before. In my opinion, what we heard yesterday was not enough to justify or sustain the rally that we've seen, and you're going to see the stock price fall considerably because of it. As I type, we are down over 16% in premarket and I expect it to keep falling after the open due to lack of news and profit-taking. An extended rally comes when scripts increase. Short term rally is shorts, short at a sp that does no make sense to stay short until the stock jumps up a bit.
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Post by Deleted on May 11, 2017 9:25:56 GMT -5
@reverselo you obviously did not paying attention to Castagna's discussion regarding scripts and cartridges. I recommend you listen again to the call to get your facts straight.
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Post by agedhippie on May 11, 2017 10:10:49 GMT -5
The thing which caught my eye was the mention of Symlin which is an interesting choice. It's an amylin analog which is interesting because amylin is one of those hormones that is lost along with insulin when beta cells are wiped out. Amylin has a role in regulating the speed of digestion and the release of glucagon to raise glucose levels. The behavior is not a million miles from the GLP-1 drugs.
Symlin has existed for a while but never really taken off because it is an injectable so you have to take two different injections per meal. It would be very interesting to see what you could do with premixed insulin and Symlin cartridges. That would eliminate the second step and provide a missing hormone.
Symlin is a nice example of the issues of focusing solely on insulin in diabetes. You have to look at the whole glucose metabolism if you want to fix this.
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Post by dreamboatcruise on May 11, 2017 11:22:12 GMT -5
The UAE Approval is already done in my opinion. You cannot import drugs that are not LEGAL and APPROVED by the country. I expect to see a PR today or tomorrow confirming this ....If I am right ...its all over for the MNKD Shorts...If I am wrong...I can wait a few more weeks. LONG MNKD. Expect a lot of Investors who know nothing about Afrezza to get scared and SELL tomorrow ...I will be buying more. It will DIP at the open for sure then go right back up. Matt referred to having filed in one Middle East country (based on accounts of those that listened to call, which I haven't yet). You think it was UAE but for some reason he was being a bit deceptive in implying approval has not yet occurred? I'm sure the discrepancy between what he said and your opinion has something to do with one of those secret master plans that can't yet be revealed but involve riches beyond belief.
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Post by peppy on May 11, 2017 11:24:17 GMT -5
The UAE Approval is already done in my opinion. You cannot import drugs that are not LEGAL and APPROVED by the country. I expect to see a PR today or tomorrow confirming this ....If I am right ...its all over for the MNKD Shorts...If I am wrong...I can wait a few more weeks. LONG MNKD. Expect a lot of Investors who know nothing about Afrezza to get scared and SELL tomorrow ...I will be buying more. It will DIP at the open for sure then go right back up. Matt referred to having filed in one Middle East country (based on accounts of those that listened to call, which I haven't yet). You think it was UAE but for some reason he was being a bit deceptive in implying approval has not yet occurred? I'm sure the discrepancy between what he said and your opinion has something to do with one of those secret master plans that can't yet be revealed but involve riches beyond belief.
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Post by mnholdem on May 11, 2017 11:35:09 GMT -5
I find the term "partnering" to be interesting and indicative that companies other than MannKind will be handling distribution of Afrezza in these countries.
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